510(k) K851058
- Device
- DOSI FLOW
- Applicant
- LEVENTON, S.A.
- 510(k) number
- K851058
- Product code
- LDR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-04-29
- Date received
- 1985-03-14
- Regulation
- 880.5725
- Classification name
- Controller, Infusion, Intravascular, Electronic
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- JUAN ALFONSO
- Address
- Poligono Can Suyer, 11 Sant Andreu De La Barca Barcelona ES 08740 08740
FDA Registration Numbers
- 1287243
- 1220973
- 1320894
- 1223925
- 3007305485
- 1018470
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 18436020769150 | DOSI-FLOW | LEVENTON SAU | 2023-09-08 |
| 18436020769167 | DOSI-FLOW | LEVENTON SAU | 2023-09-08 |
| 18436020760096 | DOSI-FLOW | LEVENTON SAU | 2016-11-30 |
| 18436020760560 | DOSI-FLOW | LEVENTON SAU | 2016-11-30 |
| 18436020760911 | DOSI-FLOW | LEVENTON SAU | 2016-11-30 |
| 18436020761369 | DOSI-FLOW | LEVENTON SAU | 2016-11-30 |
| 18436020763462 | DOSI-FLOW | LEVENTON SAU | 2016-11-30 |
| 18436020764254 | DOSI-FLOW | LEVENTON SAU | 2016-11-30 |
| 08436020767227 | Rate Flow® | LEVENTON SAU | 2016-09-16 |
| 18436020767217 | Rate Flow® | LEVENTON SAU | 2016-09-16 |
| 18436020767323 | Rate Flow® | LEVENTON SAU | 2016-09-16 |
| 18436020767231 | Rate Flow® | LEVENTON SAU | 2016-09-16 |
| 08436020767241 | Rate Flow® | LEVENTON SAU | 2016-09-16 |
| 18436020767255 | Rate Flow® | LEVENTON SAU | 2016-09-16 |
| 18436020767262 | Rate Flow® | LEVENTON SAU | 2016-09-16 |
| 18436020767279 | Rate Flow® | LEVENTON SAU | 2016-09-16 |
| 18436020767286 | Rate Flow® | LEVENTON SAU | 2016-09-16 |
| 18436020767293 | Rate Flow® | LEVENTON SAU | 2016-09-16 |
| 18436020767309 | Rate Flow® | LEVENTON SAU | 2016-09-16 |
| 18436020767316 | Rate Flow® | LEVENTON SAU | 2016-09-16 |
Legacy Summary
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FDA Review
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